Spirituality and Depression Study

This study is ongoing, but not recruiting participants.

Sponsored by:	Canadian Institute of Natural and Integrative Medicine
Information provided by:	Canadian Institute of Natural and Integrative Medicine
ClinicalTrials.gov Identifier:	NCT00322777

Purpose

The purpose of this study is to assess the efficacy of a spirituality teaching programme for unipolar major depression. Using a randomized controlled trial design it will be assessed 1) whether the programme is efficacious in improving depression severity, response rates, remission rates and quality of life and 2) whether the efficacy is maintained long term (at least half a year).

Condition	Intervention
Unipolar Depression	Behavioral: Spirituality Teaching Programme on CDs

MedlinePlus related topics: Depression

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Spirituality Teaching Programme for Depression: A Randomized Controlled Trial

Further study details as provided by Canadian Institute of Natural and Integrative Medicine:

Primary Outcome Measures:

Hamilton Depression Rating Scale (HAMD) at the end of 8 weeks
Profile of Mood Scale (POMS) at the end of 8 weeks
SF36 Health Survey at the end of 8 weeks

Secondary Outcome Measures:

Hamilton Depression Rating Scale (HAMD) at the end of 16 and 24 weeks
Profile of Mood Scale (POMS) at the end of 16 and 24 weeks
SF36 Health Survey at the end of 16 and 24 weeks

Estimated Enrollment:	120
Study Start Date:	January 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Satisfy the DSM-IV criteria for unipolar major depression with a depression score of 18-22 on the Hamilton Depression Scale (mild to moderate severity),
Are at least 18 years of age,
Have the competence to understand the study requirements and the ability to comply with the study intervention,
Have provided written informed consent.

Exclusion Criteria:

History of treatment resistance to two or more antidepressants when treated for an adequate period with a therapeutic dose
History of bipolar d/o, psychotic d/o, any psychotic episodes, personality d/o (except obsessive compulsive d/o)
History of multiple suicide attempts
Acute psychiatric condition other than unipolar depression
Regular use of medications (other than antidepressant, if applicable) that have mood altering effects, such as narcotics, anticonvulsants, illicit drugs or sleeping pills
Uncontrolled medical conditions in the last 3 months
DSM-IV diagnosis of substance abuse (except nicotine and caffeine) within the past 12-months
High suicide risk

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00322777

Locations

Canada, Alberta
Canadian Institute of Natural and Integrative Medicine
Calgary, Alberta, Canada, T2N 1B9

Sponsors and Collaborators

Canadian Institute of Natural and Integrative Medicine

Investigators

Principal Investigator:	Sabine Moritz, MSc	Canadian Institute of Natural and Integrative Medicine
Principal Investigator:	Badri Rickhi, MD	Canadian Institute of Natural and Integrative Medicine
Study Director:	Hude Quan, PhD	University of Calgary
Study Director:	Robin Reesal, MD	Centre for Depression and Anxiety

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	Spirit II
Study First Received:	May 4, 2006
Last Updated:	July 13, 2006
ClinicalTrials.gov Identifier:	NCT00322777
Health Authority:	Canada: Health Canada

Keywords provided by Canadian Institute of Natural and Integrative Medicine:

Depression
Spirituality

Study placed in the following topic categories:

Depression
Mental Disorders
Mood Disorders
Depressive Disorder
Behavioral Symptoms

ClinicalTrials.gov processed this record on January 14, 2009